US beats EU on drug review times, approvals

US regulators have outpaced their European counterparts both on the number of new medicines approved and length of review times between 2011 and 2015, shows a new analysis published by the New England Journal of Medicine.

According to the data, the US Food and Drug Administration (FDA) waved through 170 new therapeutic agents over the timeframe, compared with 144 approved by the European Medicines Agency (EMA).

Also, regulatory reviews by the FDA were 60 days shorter on average than those undertaken by its European peer, with the extent of the difference similar to, or even greater than, that seen in a previous analysis spanning 2001 and 2010, the study authors note.

Delving further into the findings, the analysis also revealed that the FDA approved 43.5 percent of applications for orphan drugs, compared with 25 percent for the EMA.

The total review times were shorter at the FDA than at the EMA for therapeutic agents used to treat cancer and haematologic disease, but not for other therapeutic areas, and for therapeutic agents that were designated as orphan drugs, the study authors note.

Among the 142 therapeutic agents that were approved by both agencies, the median total review time was 303 days for the FDA and 369 days for the EMA.

“Our analysis provides reassurance that the FDA continues to complete regulatory reviews more quickly than the EMA and has the potential to inform discussions regarding the reauthorisation of the Prescription Drug User Fee Act (PDUFA),” the authors said.

EMA relocationMeanwhile, the European parliament has confirmed that an agreement to relocate the EMA should be reached “as quickly as possible” now that the UK has officially confirmed its intent to leave the EU.

A large number of EU member states are now vying to become host nation for the Agency, including Ireland, Croatia, Malta, Spain, Portugal, Italy, France, Denmark, Sweden, Finland, Hungary, Bulgaria and the Netherlands.

The EMA has been based in London since its inception in 1995; a decision on its relocation will be made by EU heads of state.